Condition: Sepsis · Sponsor: Assistance Publique - Hôpitaux de Paris
Main objective and primary endpoint: To compare the effect hydrocortisone plus fludrocortisone vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 90 days on intensive care unit (ICU) adults and having different biological profiles for immune responses and corticosteroids bioactivity. Secondary objectives and endpoints: * Mortality and health-related quality of life at 6 months; * Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, 28, and 90); * Daily secondary infections (up to 90 days) * Daily blood and urinary levels of glucose, sodium and potassium (up to 28 day) * Daily gastroduodenal bleeding (up to 28 day) * Daily cognitive function and muscles' strength (days 1 to 28, 90 and 180 days).
This description comes directly from the study's public registry record.
Djillali ANNANE, MD, PhD · +33 1 47 10 77 87 · djillali.annane@aphp.fr
Always discuss trial participation with your own doctor first.
| Department of medical and surgical Intensive Care Unit, Raymond Poincaré Hospital - APHP | Garches, Hauts-de-Seine, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04280497